Changing Trends In Indian Clinical Trials

Indian clinical trials along with the overall healthcare vertical today are at an inflection point and are estimated to expand in the long run. However, the Indian clinical expenditure ranks still one of the lowest globally and there are other critical challenges too that needs to be addressed in terms of quality patient care and availability of health care services.  Though this represents a crucial scope for the private sector the Government sector too has an essential part to play it making the evolution possible.

The health care and the clinical trial expenditure when compared with regards to the public-private contribution, also indicates a distorted picture. It has been estimated that the private sector contribution to the India medical sector had been 75 percent and is considered as the highest globally in terms of percentage. The public expenditure on the other hand is estimated to be the lowest globally and is also 23 percent less than the global average.

However, apart from these statistical details changes in lifestyle and the emergence of new chronic ailments have given rise to the amount of clinical trials in India. This branches out from the intricacy of the non-communicable and communicable diseases both in the urban and rural regions. The occurrence of chronic disease patterns has influenced the medical infrastructure needs and has also resulted in the architectural challenges for the government as well as the private players. It has also been observed that India often gets rated poorly on the fundamental health care factors when it is benchmarked against developed economies as well as the BRIC nations. This indicates that a huge part of the Indian population is not able to have proper access to health care services. This is a result of:

• Absence of proper medical infrastructure
• Absence of qualified and trained manpower
• Absence of proper regulatory services and quality assurance

Keeping these aspects in mind Indian CRO’s (clinical research organizations) today conducts regular clinical trials concentrating on Phase I to IV medical studies. These CRO’s apart from carrying out innovative drug development and treatment process also carries out research on innovative medical studies on biometrics, medical writing, clinical pharmacokinetic, and other variations of bio-analytical studies. In additional to that, the CRO’s also excel in multiple therapeutic areas and studies related to bioavailability.

Thus, the major objective of having systematic and organized clinical trial phases is to come out with innovative treatment methods and healing modalities so that the rate of chronic ailments can be reduced eventually.

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Advanced Biometrics Service Portfolio by CRO’s

Biometrics recognitions are generally based on two principal premises about body traits, namely distinctiveness and permanence. The identification and applicability precision of a certain biometric train principally depends on to what extent these two premises hold relevance for the population at large. Face, fingerprints and iris are some of the well known physiological traits that are used in commercial biometric systems. Whilst fingerprint can capture more than 50 percent of the civilian market share.

On the other hand distinctiveness and permanence of several behavioral traits proposed in medical literature such as gait, signature and keystroke dynamics are weak. It has been observed that very less operational systems depending on these traits have been implemented so far. The selection of a certain biometric modality generally depends on the requirements and nature of the intended identification application. For instance, voice biometrics have been apt in authentication applications including mobile phones as a sensor for tracking voice is already embedded in the phone.

Indian CRO’s (Clinical Research Organizations) that conduct various clinical trials have their own dedicated Biometrics teams capable of helping clients at multiple levels of the trails and medical studies. They assist the clients with their advanced technologies and skill to come up with study designs, analysis processes, and interpretations and provide help with the overall clinical development program. The teams are further backed up by the new age software applications including Win non line and SAS.

Clinical research organizations (CRO) in India today offer a complete range of data management services in bioequivalence along with Phase I-IV clinical trials. The objective is to convert raw data into accurate, inconsistent and dependable trial output staying in compliance with regulatory services. The CRO’s have the ability to manage multi-centric studies for global and domestic needs in various therapeutic areas. The Biometric services provided by them are used by several biotechnology, device, and pharmaceutical and other medical research organization. The service portfolio includes the following:

Database Programming

• CRF Design (paper & electronic)
• CRF Annotation
• Database Programming
• Validation Checks
• Metadata Repository Management

Data Management

• Data Acquisition
• Data Reconciliation
• Discrepancy Management
• Medical Coding (MeDRA & WHODD)
• Database Lock
• Data Extraction for Reporting

Pharmacokinetic & Pharmacodynamic Studies

• Sampling Point Estimation
• Technical Document Review
• PK/PD Query Resolution
• PK/PD Subject Matter Expert
• Clinical Pharmacokinetic support across study engagement

PK/PD Reporting

• SDMS Data Extraction
• PK Data Analysis
• PK Summary Reporting

Biostatistics

• Randomization
• Sample size estimation
• Trial Design Inputs
• Statistical Analysis Plan
• Statistical Analysis
• Biostatistics Subject Matter Expert

Statistical Reporting

• TLF Programming
• CDISC Data Mapping (SDTM & ADaM)
• Clinical Data Repository
• Pooled Data Analysis & Reporting
• Safety (ADR) Reporting
• Patient Profiles & Data Cleaning Reporting

Biometrics team in the CRO’s is expert to support their clients at every Clinical trial stage. The biometric services include statistical analysis, protocol writing and report writing and the team is well equipped by advanced software such as SAS and WIN NonLin.

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Regulatory Services Offered By Indian CRO’s.

India over the last decade has come up with various developments and advancements in medical trials and in project and data management. India has been successfully able to provide cost savings of 50 to 60 percent in clinical trials. With the research discovery acquiring approximately one-third of the R&D expenses of the western medical industry, outsourcing to lesser expense countries is a wise move. With the financial and regulatory pressure expanding in the US and European medical industry, it is estimated to propel the development in the Indian clinical trial market.

All this has compelled the clinical research organizations (CRO) in India to introduce advanced clinical laboratory services that assist in disease treatment and drug development. The medical doctors and technicians’ research experiment and conduct different medical studies and experiments and review human blood sample and assesses blood samples and evaluate the impact of drugs on the blood. This apart, the CRO’s also give importance to regulatory compliance services and appropriate quality assurance. There is a separate team for regulatory services and audit compliance that is in turn supported by a vast knowledge of the local regulatory procedures and helpful associations with various regulatory agencies ensuring perfection in the clinical trial approval process. Rigid healthcare budgets, patent expiries and stricter regulatory climate are some of the essential challenges that the medical industry witnesses today.

Renowned Indian CRO’s specializing in regulatory services has completed various audits from multiple global and Indian regulatory agencies. Simultaneously, there have been study submissions from multiple countries. The vast range of regulatory services offered includes the following:

• Formulating regulatory strategies
• Replying regulatory agency queries
• Renewing Import License
• Procuring drug import licenses
• Follow-up and submissions on the application
• Tracking applications and approvals
• Submission of Clinical Safety Report (CSR)
• Safety Reporting
• Procuring NOC for export of biological samples
• Compiling a clinical trial application

In addition to that, with regards to QA Indian CRO’ s have a complete quality assurance team to manage the same with a standard quality. The team focuses on quality that permeates through the processes within the domain of each single process. In addition to that, there are thorough implementations that are carried out by the Quality Assurance and Quality Control processes. QA practices span across Bioanalytical, Clinical, Statistics, Internal Audits and Reporting by the QA team for area specific SOP compliance. Simultaneously, there are other in-house capacities that CRO’s perform and includes of components such as Site Audits, Vendor Audits, Process/System Audits, and Document Audits that includes protocol, clinical study reports and important clinical trial documents.

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